In what GlaxoSmithKline (NYSE: GSK) says is a first, the drug giant has received FDA approval for a combination of its cancer drugs that target a form of melanoma linked to specific genetic mutations.
The FDA granted GSK “accelerated approval” for the use of its cancer drugs Tafinlar and Mekinist to treat melanoma that can’t be removed by surgery or has spread to other parts of the body and is linked to two mutations known as BRAF V600E and V600k.
FDA approval was announced late Wednesday.
The genetic mutations must be detected by an FDA-approved test before a patient can be treated.
GSK said the FDA granted approval based on the “response rate and median duration of response” in a Phase 1/2 trial.
Approval is contingent on results of a Phase 3 trial that is ongoing.
“This approval marks another key moment in what continues to be a rapid evolution of the treatment landscape for metastatic melanoma patients. Combining agents that target different mechanisms regulating the growth of cancer cells is one of the promising areas in cancer research,” said Dr. Paolo Paoletti, president of Oncology at GSK. “We are proud that the first approved combination of targeted therapies in metastatic melanoma is Mekinist and Tafinlar, and our hope is that it will become part of the new standard of care for appropriate patients with BRAF V600E or V600K mutation-positive metastatic melanoma.”
GSK operates its North American headquarters in RTP.
Full details about the approval are available online.
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